Persistent Atrial FibrillationPhase 4CAPAPAF-65NCT02528604
Electrical Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation
A Phase 4 study testing Catheter ablation, Pacemaker and AV node ablation and DC Cardioversion in people with Persistent Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 2 sites in United Kingdom.
Trial summary
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Catheter ablation, Pacemaker and AV node ablation and DC Cardioversion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2016to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.
- Patients must be over 65 years old.
- Patients give informed consent prior to participating in this study.
Who cannot join
- Paroxysmal atrial fibrillation.
- Long-standing persistent or permanent atrial fibrillation.
- Previous pacemaker implantation.
- Previous atrial ablation.
- Patient is unable to take warfarin or other oral anti-coagulant medication.
- Patient is suffering with unstable angina in last one week.
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- Patient has had a myocardial infarction within last two months.
- Patient is expecting or has had major cardiac surgery within last two months.
- Patient is participating in a conflicting study.
- Patient is unable to perform exercise testing.
- Patient is mentally incapacitated and cannot consent or comply with follow-up.
- Patient has New York Heart Association (NYHA) class III/IV heart failure.
- Patient has left ventricular ejection fraction (LVEF) less than 35% not secondary to tachycardia.
- Pregnancy.
- Patient suffers with other cardiac rhythm disorders.
- Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
Conquest Hospital
Saint Leonards-on-Sea, East Sussex, TN37 7RD
About this study
Official title: Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
Read the detailed description
the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:
- Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.
- Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.
- Left atrial catheter ablation.
These treatment options have not been directly compared and each has their own advantages and disadvantages.
- DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.
- Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.
- Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Catheter ablation, Pacemaker and AV node ablation, DC Cardioversion, Implantable loop recorder
- Keywords
- Catheter Ablation, Permanent pacemaker, AV node ablation, Electrical Cardioversion, Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.
Pacemaker and AV node ablationProcedure or surgery
Permanent pacemaker implant followed by AV node ablation
DC CardioversionProcedure or surgery
Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.
Implantable loop recorderDevice
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation | Active comparator | Left atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder. Receives: Procedure: Catheter ablation; Device: Implantable loop recorder |
| Pacemaker and AV node ablation | Active comparator | Participants will have a permanent pacemaker implant followed by AV node ablation Receives: Procedure: Pacemaker and AV node ablation |
| DC cardioversion | Active comparator | Participants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder. Receives: Procedure: DC Cardioversion; Device: Implantable loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
Time to recurrence of persistent AF
Measured: 12 months
Secondary outcomes (7)
Patient experience of procedure
Patient experience of each procedure will be assessed by validated questionnaires
Measured: Baseline
Total costs of the treatment options
Measured: 12 months
AF recurrence >2minutes
Time to recurrence of AF episode > 2 minutes
Measured: 12 months
Symptoms / QOL
To assess differences in symptoms and QOL
Measured: 12 months
Exercise performance
To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.
Measured: 12 months
AF burden
To measure the three treatment effects on AF burden
Measured: 12 months
Sleep apnoea
To assess the impact of the three treatment options on sleep apnoea scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJul 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rick Veasey, East Sussex Healthcare NHS Trust
- Investigators
- Rick A Veasey, MRCP, MD, Principal investigator, Consultant Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528604
- Sponsor's protocol ID
- CAPAPAF-65 V2.0
- Acronym
- CAPAPAF-65
- Status last verified
- Sep 2018
- First submitted
- 18 Aug 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioversion, Ablation or Pace and Ablate for Persistent Atrial Fibrillation in Over 65s - The CAPAPAF-65 Study
- ClinicalTrials.gov ID
- NCT02528604
- Acronym / sponsor ID
- CAPAPAF-65 / CAPAPAF-65 V2.0
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Catheter Ablation, Permanent pacemaker, AV node ablation, Electrical Cardioversion, Implantable loop recorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
Detailed description
the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation:
- Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment.
- Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation.
- Left atrial catheter ablation.
These treatment options have not been directly compared and each has their own advantages and disadvantages.
- DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times.
- Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform.
- Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Active comparator | Procedure: Catheter ablation, Device: Implantable loop recorderLeft atrial catheter ablation for persistent atrial fibrillation and implantable loop recorder. |
| Pacemaker and AV node ablation | Active comparator | Procedure: Pacemaker and AV node ablationParticipants will have a permanent pacemaker implant followed by AV node ablation |
| DC cardioversion | Active comparator | Procedure: DC Cardioversion, Device: Implantable loop recorderParticipants will have electrical cardioversion with concomitant anti-arrhythmic therapy and implantable loop recorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptomatic persistent atrial fibrillation of less than 1-year duration.
- Patients must be over 65 years old.
- Patients give informed consent prior to participating in this study.
Key exclusion criteria (16 listed)
- Paroxysmal atrial fibrillation.
- Long-standing persistent or permanent atrial fibrillation.
- Previous pacemaker implantation.
- Previous atrial ablation.
- Patient is unable to take warfarin or other oral anti-coagulant medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationLeft atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion. | Procedure or surgery | Catheter Ablation |
| Pacemaker and AV node ablationPermanent pacemaker implant followed by AV node ablation | Procedure or surgery | Pacemaker and AV node ablation |
| DC CardioversionElectrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion. | Procedure or surgery | DC cardioversion |
| Implantable loop recorder | Device | Catheter Ablation, DC cardioversion |
Primary outcome
AF recurrence
Time frame: 12 months
Time to recurrence of persistent AF
7 secondary outcomes
Patient experience of procedure
Time frame: Baseline
Total costs of the treatment options
Time frame: 12 months
AF recurrence >2minutes
Time frame: 12 months
Symptoms / QOL
Time frame: 12 months
Exercise performance
Time frame: 12 months
AF burden
Time frame: 12 months
Sleep apnoea
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick A Veasey, MRCP, MD principal investigator
Consultant Cardiologist
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Catheter ablation, Pacemaker and AV node ablation and DC Cardioversion in people with Persistent Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.